For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead.
- Key Questions To Ask When Entering A Pharma Partnership
- Container Closure Integrity Testing Strategies For Gene Therapies
- Targeting Von Willebrand Factor With An RNA Aptamer To Treat Stroke
- Rocketing Expectations For CDMOs
- Will Point-Of-Care Manufacturing Unlock The Value Of Autologous Cell Therapies?
- The Business Case For Pharmaceutical Continuous Manufacturing
- Should My Biotech Startup Buy Or Produce The Proteins We Use?
Key Questions To Ask When Entering A Pharma Partnership
Before entering a partnership, pharma and biotech executives need to ask themselves and their prospective partners key questions in five important areas.
Container Closure Integrity Testing Strategies For Gene Therapies
Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.
Targeting Von Willebrand Factor With An RNA Aptamer To Treat Stroke
Developing new treatments for acute ischemic stroke that can quickly and safely intervene at the right place and time has been a challenging endeavor. Today, the situation is changing due to technological developments related to stroke and recent advances in RNA-based medicines.
Will Point-Of-Care Manufacturing Unlock The Value Of Autologous Cell Therapies?
To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC compresses the vein-to-vein process, brings production closer to the patient, and has the potential to address other ongoing concerns, such as reduction of risks and costs.
The Business Case For Pharmaceutical Continuous Manufacturing
Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
Should My Biotech Startup Buy Or Produce The Proteins We Use?
"Should we build out an internal group of scientific expertise or delegate work to external vendors?," is a question that this author has faced in his career. He shares key considerations building protein science teams.
How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?
Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.
Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead
Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.
PHARMA OUTSOURCING WHITE PAPERS
Optimizing Your Clinical To Commercial Journey
How should you think about optimizing the journey from the development stage of clinical trials to commercialization? Review considerations to eliminate avoidable delays and have a seamless transition.
Early Planning To De-Risk Development: Strategy & Study Design
Access insightful guides and checklists that provide valuable advice and best practices for planning and executing effective nonclinical studies.
Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Product Development
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
Regulatory Considerations For Alternative Microbial Methods
This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
Digital Transformation In Regulatory: Achieving Excellence Virtually
As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.
Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Streamlining The Integrity Testing Process – From Test To Report
- Mechanistic Modeling: Digital Twins Are Here To Stay
- How Integrated CMC Can Help Expedite Early Phase Development Of Small Molecules — A CRO Perspective
- Deliver Product Quality, Enhance Productivity In CHO-K1, CHO-S Cells
- Streamlining Cell Therapy Delivery With Efficiency-Led Design
- 06.09.23 -- Computational Biology's Role in Gene Therapy, Building Flagship Pioneering, and more episodes to check out!
- 06.09.23 -- Have Questions About Your Small Molecule API And Drug Product Projects?
- 06.08.23 -- Ensure Protein Stability Through Biophysical Characterization
- 06.07.23 -- Discover The New Possibilities For Increased Dosing Capabilities Offered By Nanoformed APIs
More women are entering and making significant gains in our drug development and manufacturing outsourcing sector. In this e-book, Chief Editor Louis Garguilo highlights a few of these individuals, and takes account of the current environment for women who do enter our industry.More Content Collections